Supervisor Device Quality Control, 1st shift- Exton, PA
About The Position
As a Supervisor, Device Quality Control, you will work closely with all areas of Operations in order ensure that DSM products are of consistent and high quality by: Operating as a liaison for the QC department, supporting the continuous improvement of Processes and coordinating non-routine tests involved with method improvement, process optimization studies, and validation and qualification projects, approving testing results including second signature approval, writing and revising SOPs, ensuring the operating status and calibration of laboratory instruments and equipment. Biomedical is the world’s unrivaled biomaterials expert and committed partner in driving sustainable innovation in healthcare.
Requirements
- Associate degree in applicable field. BS degree preferred a plus. Years of experience may be substituted for degree. GMP/GDP and Cleanroom familiarity is a plus
- Minimum 5 years of experience. 6-10 years of experience in related GMP/GDP environment with a High School Diploma.
- Inspection and testing experience within a GMP or ISO 9001 and ISO 13485 environment.
- Ability to speak with various levels of personnel within the business, including operators who test the medical devices, functional department colleagues, managers and at times with external audit bodies and customers.
- Knowledge of commonly used concepts, practices, and procedures within a QC environment. Knowledge & understanding of sampling techniques. (ANSI/ASQC Z1.4-2003) Must have excellent writing, editing and proofing skills and proficient using MS Word, Excel, and Outlook.
- Knowledge & understanding of sampling techniques. (ANSI/ASQC Z1.4-2003)
- Must have excellent writing, editing and proofing skills.
- Proficient using MS Word, Excel and Outlook.
Nice To Haves
- BS degree preferred a plus.
- GMP/GDP and Cleanroom familiarity is a plus
Responsibilities
- When necessary, perform routine inspections and/or analytical testing of in-process components, finished products and documentation of results, in accordance with DSM Standard Operation procedures and all safety requirements as assigned.
- Lead training/Cross training and onboarding of new team members as a onboarding Buddy
- Provide Audit/Inspection support when needed and drive any corrective actions stemming from such occurrences.
- Drive necessary improvements to Lab procedures/processes using the ECR/ECO process.
- Ensure the operating condition of equipment and instruments in the lab, troubleshoot equipment and instrument problems, coordinate repair.
- Ensure routine equipment maintenance and calibration is performed per the required schedule.
Benefits
- Paid holidays, 18 days PTO + 2 floating holidays.
- Full healthcare benefits day one - medical, dental, eye and life insurance.
- 401K with generous company match.
- A competitive compensation package, with comprehensive health and welfare benefits.
- A place to grow and develop.
- A company that is purpose-led and performance-driven in a corporate culture that values people and planet.
- The opportunity to work on growing brands and build on a strong foundation.
- The chance to make improvements and make an impact on the business.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Associate degree
